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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES ASEPTICO 30K ELECTRIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED

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DENTSPLY TULSA DENTAL SPECIALTIES ASEPTICO 30K ELECTRIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number AM4B
Device Problem Failure to Calibrate (2440)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Additional information was received indicating there was no injury to the patient.
 
Manufacturer Narrative
There has been a previous report received where a calibration malfunction has caused file separation. Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803. Evaluation found a broken rotor magnet.
 
Event Description
It was reported that an aseptico 30k electric motor was not calibrating and was overheating. The event outcome is unknown as of this mdr evaluation.
 
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Brand NameASEPTICO 30K ELECTRIC MOTOR
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
DENTSPLY TULSA DENTAL SPECIALTIES
608 rolling hills drive
johnson city TN 37604
Manufacturer (Section G)
ASEPTICO, INC
8333 216th st se
woodinville WA 98072
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7000223
MDR Text Key250348037
Report Number2320721-2017-00068
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAM4B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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